Clinical Trials Logo

Clinical Trial Summary

The only known cure for primary hyperparathyroidism is surgical removal of one or more parathyroid glands. Some patients however, do not fulfill criteria for surgery or do not want to undergo a procedure due to fear of the associated risks. Therefore a medical alternative is warranted. This study aims to evaluate the effects of Denosumab alone, and in combination with Cinacalcet, as a medical treatment for patients suffering from primary hyperparathyroidism, with mild osteoporosis. To the best of our knowledge no previously reported randomized controlled trial has investigated the use of denosumab in primary hyperparathyroidism. 60 patients will be enrolled in three different treatment-groups: 20 receiving both Denosumab and Cinacalcet, 20 Denosumab and placebo and 20 placebo and placebo. Patients included do not meet the criteria for, or have no wish for a surgical procedure. By combining the two drugs, this study could possibly contribute to the discovery of a realistic medical alternative to surgery. It is expected that the therapy will be able to both control s-calcium and s-intact parathyroid hormone (iPTH), and simultaneously enhance bone-structure. The therapy thus has the potential of preventing fractures and possibly other long-term effects of primary hyperparathyroidism such as formation of kidney stones, and coronary calcification. Another objective of this project is to investigate whether the combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby de facto cure the disease.


Clinical Trial Description

Background/Context: This project deals with medical treatment of primary hyperparathyroidism. The only cure currently available is surgical removal of one or more parathyroid glands, but this option is neither feasible, nor desirable in all patients with the diagnosis. Today a major group of patients are being diagnosed by coincidence with biochemical blood-screening, and are therefore in an asymptomatic state of the disease at the time of diagnosis. Long term studies show that these patients over time often have progression in their disease, and develop complications such as osteoporosis. Thus a medical alternative is warranted. Previous studies have investigated the effects of well known antiresorptive drugs such as bisphosphonates, as well as estrogen-related compounds. These drugs have had effects on particularly bone mineral density (BMD) and biochemical bone-turnover markers, but have been able only transiently to lower blood-calcium levels. Combined with too many unwanted side-effects and a high prevalence of contraindications for a large proportion of the patients needing treatment, these drugs have not provided a realistic alternative to surgery. Treatment today generally follows the international consensus for treatment of asymptomatic patients with primary hyperparathyroidism. Briefly this includes watchful waiting with biannual control-sessions for indication of surgery, screening for kidney stones/nephrolithiasis, osteoporosis and s-calcium - and s-iPTH levels. This randomized controlled trial involves the drugs Cinacalcet og Denosumab. Denosumab has previously been shown to greatly improve BMD, lower s-calcium, lower the rate of bone-turnover and prevent osteoporotic fractures in several populations with different diseases, but has never been tested in a published randomized controlled trial in patients with primary hyperparathyroidism. Cinacalcet has been proved able to lower s-iPTH, lower s-Calcium and thereby relieve symptoms of hypercalcaemia caused by primary hyperparathyroidism. It does not however, lower the rate of bone turnover, and it has not been show to improve BMD. By combining the two drugs, this study could possibly contribute to the discovery of a realistic medical alternative to surgery. It is expected that the therapy will be able to both control s-calcium and s-iPTH, and simultaneously enhance bone-structure. The therapy thus has the potential of preventing fractures and possibly other long-term effects of primary hyperparathyroidism such as formation of kidney stones, and coronary calcification. Another objective of this project is to investigate whether the combined therapy can facilitate an actual reset of the Calcium-sensing receptor, and thereby de facto cure the disease. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03027557
Study type Interventional
Source Aalborg University Hospital
Contact
Status Completed
Phase Phase 3
Start date March 1, 2017
Completion date September 12, 2019

See also
  Status Clinical Trial Phase
Active, not recruiting NCT03931109 - Circulating miRNA in Primary Hyperparathyroidism
Completed NCT04305561 - Preoperative Localization Strategies in Primary Hyperparathyroidism N/A
Recruiting NCT03052075 - Percent Change in Baseline Bone Mineral Density (BMD) After Parathyroidectomy in Patients With Primary Hyperparathyroidism
Completed NCT03774771 - Safety, Pharmacokinetics, and Clinical Effects of Cinacalcet (AMG 073) in Primary Hyperparathyroidism Phase 2
Recruiting NCT02854345 - Preliminary Study Concerning the Validity of Parathyroid Exploration on a CZT Camera N/A
Completed NCT01222026 - Systematic Treatment After Successful Surgical Treatment for Primary Hyperparathyroidism With Strontium Ranelate Phase 4
Recruiting NCT00973336 - Primary Hyperparathyroidism: Does a Systematic Treatment Improve the Calcium and Bone Metabolism After Surgery? Phase 2
Completed NCT01530919 - Minimally Invasive Radioguided Parathyroidectomy N/A
Recruiting NCT03605472 - Comparison of Cervical Ultrasound and Echoscintigraphy for Preoperative Localization Diagnosis in Primary Hyperparathyroidism N/A
Completed NCT01306656 - Vitamin D Repletion in Primary Hyperparathyroidism Phase 4
Terminated NCT00961701 - Lipids Profile in Primary Hyperparathyroidism N/A
Completed NCT00432939 - Primary Hyperparathyroidism: Non-classical Manifestations N/A
Completed NCT00522028 - Asymptomatic Primary Hyperparathyroidism: A Prospective, Randomized Trial N/A
Completed NCT03713671 - Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism N/A
Recruiting NCT04969926 - Natural History Study of Parathyroid Disorders
Recruiting NCT03039439 - Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors
Not yet recruiting NCT03732157 - Feasibility of Parathyroidectomy With Exploration of 4 Parathyroid Glands in Outpatients
Completed NCT01996072 - EC17 for Intraoperative Imaging for Parathyroidectomy Phase 1
Completed NCT01460030 - An Intra-individual Titration Study of KRN1493 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Intractable Primary Hyperparathyroidism Phase 3
Enrolling by invitation NCT04085419 - Osteoporosis in Primary Hyperparathyroidism Phase 4